National Bioengineered Food Disclosure Standard Final Rule Released

Thursday, December 20, 2018

After much anticipation, the Agricultural Marketing Service (AMS) has released the final rule establishing the national mandatory bioengineered (BE) food disclosure standard. The rule is scheduled to be published on December 21, 2018 in the Federal Register. As previously reported on this blog, the proposed rule was published on May 4, 2018 and approximately 14,000 comments were received by the end of the comment period. The final rule includes a number of significant provisions related to applicability, disclosure requirements, administrative provisions, and compliance dates.

We will release a comprehensive client alert on the final rule within the week, so while this blog cannot cover all areas of the final rule, below are some of the issues of interest:

Highly refined ingredients, detectability, and voluntary disclosure: the rule’s definition of “bioengineered food” specifically excludes foods where modified genetic material is not detectable and includes provisions for how regulated entities can use records to demonstrate that modified genetic material is not detectable, which would remove those foods from the requirement to disclose. However, if an entity wishes to disclose a food made with ingredients derived from a BE source, where the genetic material does not have detectable modified genetic material, the rule allows for entities to make a voluntary disclosure, creating a voluntary “derived from bioengineering” disclosure.

List of Bioengineered Foods: the final rule adopts one single “List of Bioengineered Foods” to identify the crops or foods that are bioengineered to help regulated entities determine whether a food must bear a BE disclosure. Canola, corn, soybean, and sugarbeet, among others, are included. Updates to the List will be done through rulemaking on an annual basis.

Exemptions from disclosure, including a threshold allowance and incidental additives: the final rule adopts a threshold for inadvertent or technically unavoidable presence of bioengineered substances of up to 5% for each ingredient, with no allowance for any BE presence that is intentional. Moreover, the final rule also exempts incidental additives that are present in food at an insignificant level and do not have any technical or functional effect in the food.

4 disclosure options: In addition to the text (“bioengineered food” or “contains a bioengineered food ingredient”), symbol, and electronic disclosure, USDA adopted an additional text message disclosure option. The chosen symbol is one of the symbols USDA filed with the U.S. Patent and Trademark Office after the comment period ended for the proposed rule

Implementation and compliance dates: the final rule establishes implementation dates of January 1, 2020 for entities other than small food manufacturers and January 1, 2021 for small food manufacturers; entities are to begin implementing the standard no later than those dates. The final rule also establishes a mandatory compliance date, January 1, 2022, for all regulated entities, and a compliance period for voluntary labeling, which ends on December 31, 2021.

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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